Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Vyndamax: 61 mg
Mechanism of Action
Tafamidis is a transthyretin (TTR) stabilizer that selectively binds to TTR at the thyroxine binding sites and stabilizes the tetramer of the TTR transport protein, slowing monomer dissociation into monomers which is the rate-limiting step in the amyloidogenic process. Tafamidis stabilizes both wild-type TTR tetramers and the tetramers of 14 TTR variants when tested clinically as well as 25 TTR variants tested ex vivo.
Tafamidis: Vdss: 18.5 L
Tafamidis: Not fully established; glucuronidation has been observed
Tafamidis meglumine: Feces: ~59% (unchanged); Urine: ~22% (glucuronide metabolite)
Tafamidis: Clearance: 0.236 L/hour
Time to Peak
Tafamidis: 4 hours
Tafamidis: ~49 hours
Tafamidis: >99%, primarily TTR
Use in Specific Populations
Special Populations: Hepatic Function Impairment
In moderate hepatic impairment (Child-Pugh class B), tafamidis systemic exposure decreased (~40%) and clearance increased (~68%) compared to healthy subjects. Since TTR levels are lower with moderate hepatic impairment, exposure of tafamidis relative to the amount of TTR is sufficient to maintain stabilization of the TTR tetramer in these patients.
Use: Labeled Indications
Amyloid cardiomyopathy: Treatment of the cardiomyopathy of wild type or hereditary transthyretin-mediated amyloidosis (ATTR-CM) in adults to reduce cardiovascular mortality and cardiovascular-related hospitalization.
There are no contraindications listed in the manufacturer's labeling.
Dosage and Administration
Amyloid cardiomyopathy: Oral:
Note: Tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) are not substitutable on a per mg basis.
Tafamidis (Vyndamax): 61 mg once daily.
Tafamidis meglumine (Vyndaqel): 80 mg once daily.
Refer to adult dosing.
Oral: Swallow capsules whole; do not crush or cut.
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).
There are no adverse reactions listed in the manufacturer's labeling.
- Appropriate use: Equivalency: Tafamidis (Vyndamax) and tafamidis meglumine (Vyndaqel) are not substitutable on a per mg basis.
Information related to tafamidis use in pregnancy is limited and based on doses of 20 mg/day. Based on adverse events observed in animal reproduction studies, the manufacturer recommends pregnancy planning and pregnancy prevention in females of reproductive potential.
- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for health care professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience, and judgment in diagnosing, treating, and advising patients.